2015 PDA Aging Facilities Workshop Wednesday, March 18, 2015

2015 PDA Aging Facilities Workshop March 18 – 19, 2015 | Red Rock Casino Resort and Spa | Las Vegas, NV Preliminary Draft Program Agenda as of February 20, 2015 Wednesday, March 18, 2015 12:00 p.m. ‐ 5:30 p.m. Registration Open 1:00 p.m. ‐ 1:10 p.m. Welcome and Opening Remarks Glenn Wright, Senior Director, Project Management, Manufacturing Science and Technology, Eli Lilly & Company and Co‐Chair, 2015 PDA Aging Facilities Program Planning Committee 1:10 pm. ‐ 2:30 p.m. P1 – What Do We Mean By Aging and Modernization? Moderator: Glenn Wright, Senior Director, Project Management, Manufacturing Science and Technology, Eli Lilly & Company Session Description: When we talk about an aging facility we are in most cases talking about not only the facility itself but also the manufacturing processes and analytics used in producing the drug substance or drug product. This session will discuss the meaning of aging and modernization from an analytics, facility and process perspective. 1:10 p.m. ‐ 1:30 p.m. Facility Perspective George Wiker, Vice President, US‐Life Sciences and Chemicals Market Segment Lead, M+W US, Inc. 1:30 p.m. ‐ 1:50 p.m. Process Perspective Robert Dream, International Director, HDR Company, LLC 1:50 p.m. ‐ 2:10 p.m. Analytics Perspective Susan Schniepp, Independent Consultant 2:10 p.m. ‐ 2:30 p.m. Questions and Answers/Discussion 2:30 p.m. ‐ 3:00 p.m. Refreshment Break 3:00 p.m. ‐ 4:30 p.m. P2 ‐ Modernization Case Studies Moderator: Robert Dream, International Director, HDR Company, LLC Session Description: How does one approach the task of modernizing an aging facility? It’s complex with financial, technical, regulatory, and supply chain impacts? This session will provide case studies discussing the need for continuous improvement, what happens when continuous improvement is not performed. 3:00 p.m. ‐ 3:30 p.m. Hospira Modernization ‐ Case Study Craig Johnson, Vice President, Global Engineering, Hospira, Inc. 3:30 p.m. ‐ 4:00 p.m. Modernization Programs Under Consent Decree ‐ Case Study Phil DeSantis, Principal Consultant, DeSantis Consulting Associates 4:00 p.m. ‐ 4:30 p.m. Sacrificing Routine Upgrades for Manufacturing Purposes ‐ Case Study William Smith, Director, Technical Services, B. Braun Medical 4:30 p.m. ‐ 5:30 p.m. P3 ‐ FDA Perspective on Aging Facilities and Modernization Activities Breakout Session Introductions Moderator: Robert Dream, International Director, HDR Company, LLC Session Description: This Session will provide attendees with an informative perspective from the US FDA and will set the stage for tomorrow’s set of interactive breakout sessions. 4:30 p.m. ‐ 4:50 p.m. U.S. FDA Perspective Capt. Sharon Thoma, PharmD, National Expert, Pharmaceutical Inspections, ORA, FDA 4:50 p.m. ‐ 5:30 p.m. Questions and Answers/Panel Discussion and Breakout Sessions Introductions Panelists Phil DeSantis, Principal Consultant, DeSantis Consulting Associates Craig Johnson, Vice President, Global Engineering, Hospira, Inc. Maik Jornitz, President, G‐Con Manufacturing, Inc. William Smith, Director, Technical Services, B. Braun Medical Capt. Sharon Thoma, PharmD, National Expert, Pharmaceutical Inspections, ORA, FDA 5:30 p.m. ‐ 6:45 p.m. Networking Reception Thursday, March 19, 2015 7:00 a.m. ‐ 4:30 p.m. Registration Open 7:00 a.m. ‐ 8:00 a.m. Continental Breakfast Interactive Breakout Sessions 8:00 a.m. ‐ 9:30 a.m. Interactive Breakout Sessions: What Challenges Have Limited Our Ability to Modernize? Breakout Working Group Instructions: These breakout sessions will provide the opportunity for participants to their views and concerns regarding what challenges have limited the ability to modernize. Each facilitator will summarize their breakout discussions and outcomes during the last session of the day. Breakout Group 1 – Facility Breakout Group 2 – Process Breakout Group 3 – Analytics
Facilitator and Presenter:
Facilitator and Presenter: Facilitator and Presenter:
Phil DeSantis, Principal Consultant, DeSantis Consulting Associates Scribe: Shelly Preslar, Vice President, Southeast Operations, Azzur Group John Lewis, Process and Technology Director, DPS Consulting, Inc. Scribe: Robert Dream, International Director, HDR Company, LLC Marsha Stabler Hardiman, Senior Consultant, ConcordiaValSource 9:30 a.m. ‐ 10:15 a.m. Refreshment Break 2
Scribe: Susan Schniepp, Independent Consultant Interactive Breakout Sessions 10:15 a.m. ‐ 12:00 p.m. Interactive Breakout Sessions: Developing Methodologies for Modernization Approaches Breakout Working Group Instructions: These breakout sessions will provide attendees the opportunity to work together to understand and develop concepts and approaches for modernization as well as identifying current challenges that slow improvement efforts. Each facilitator will summarize their breakout discussions and outcomes during the last session of the day. Breakout Group 1 – Facility Breakout Group 2 – Process Breakout Group 3 – Analytics
Facilitator and Presenter:
Facilitator and Presenter: Facilitator and Presenter:
Phil DeSantis, Principal Consultant, DeSantis Consulting Associates Scribe: Shelly Preslar, Vice President, Southeast Operations, Azzur Group John Lewis, Process and Technology Director, DPS Consulting, Inc. Scribe: Robert Dream, International Director, HDR Company, LLC Marsha Stabler Hardiman, Senior Consultant, Concordia ValSource Scribe: Susan Schniepp, Independent Consultant 12:00 p.m. ‐ 1:15 p.m. Lunch 1:15 p.m. ‐ 2:45 p.m. P4 – Applications of Modernization Planning and Breakout Session Introductions Moderator: Marsha Stabler Hardiman, Senior Consultant, ConcordiaValSource Session Description: This session will discuss risk management of new technology implementation and modernization planning from the perspectives of a large and small scale pharmaceutical company. 1:15 p.m. ‐ 1:40 p.m. A CMO Perspective Michael Jenkins, PhD, Vice President, Business Development for Biologics, Asia Pacific, Catalent Pharma Solutions 1:45 p.m. ‐ 2:00 p.m. Risk Assessments Priscilla Robinson, PhD, Executive Director, Sterile Quality Assurance, Merck & Co., Inc. 2:00 p.m. ‐ 2:25 p.m. Proactively Planning for Facility Modernization Jason Duff, Director, Design and Profiling, Global Facilities Delivery, Eli Lilly & Company 2:25 p.m. ‐ 2:45 p.m. Questions and Answers/Discussion and Breakout Session Introductions 2:45 p.m. ‐ 3:15 p.m. Refreshment Break 3:15 p.m. ‐ 4:20 p.m. P5 ‐ Breakout Readout Report Summaries Moderator: Maik Jornitz, President, G‐Con Manufacturing, Inc. Session Description: During this session, each facilitator will be given 20 minutes to summarize the key discussion points from the two previous interactive breakout sessions. The presented slides will capture the most prominent themes from the breakout groups as expressed by the Aging Facilities Workshop participants as understood by the facilitators. They do not represent a complete summary of all ideas and comments. 3:15 p.m. ‐ 3:30 p.m. Facility Readout Report Phil DeSantis, Principal Consultant, DeSantis Consulting Associates 3:30 p.m. ‐ 3:45 p.m. Process Readout Report John Lewis, Process and Technology Director, DPS Consulting, Inc. 3:45 p.m. ‐ 4:00 p.m. Analytics Readout Report Marsha Stabler Hardiman, Senior Consultant, Concordia ValSource 3
Session P5 continued 4:00 p.m. ‐ 4:20 p.m. Questions and Answers/ Discussion 4:20 p.m. – 4:30 p.m. Workshop Summary and Closing Remarks Maik Jornitz, President, G‐Con Manufacturing, Inc. and Co‐Chair, 2015 PDA Aging Facilities Program Planning Committee 4